- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02787655
Aerobic Exercise and Cognitive Training in Older Adults
The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. It is hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability.
To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of executive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose: The purpose of this study is to examine the impact of a combined cognitive training and aerobic exercise intervention in sedentary older adults. Recent research demonstrated that older adults who participated in aerobic fitness training significantly increased their brain volume. Equally important, the demonstrated enhancement in brain size is related to improvement on specific cognitive tasks. For example, researchers demonstrated that 124 older adults randomly assigned to receive aerobic training experienced substantial improvement in cognitive performance tasks related to speed of processing and working memory. Similarly, neuroimaging studies showed that aerobically trained individuals increased brain activation during various cognitive tasks.
A growing body of research also demonstrates the beneficial effects of cognitive training in later life to promote a healthy brain. For example, researchers demonstrated cognitive interventions targeting memory, reasoning and speed of processing were effective to improve brain function. Unfortunately, despite these promising findings, the generalizability of cognitive training is limited. For example, researchers showed cognitive training tasks designed to improve reasoning, memory, planning, spatial skills and attention in over 11,000 participants demonstrated no transfer effects to untrained tasks, even when the tasks were closely related. The purpose of this study is to see if combing aerobic exercise and cognitive training can enhance the cognitive improvement of each. Specially, the investigators wish to determine if aerobic exercise done immediately before cognitive training can potentiate the improvement.
The investigators hypothesized that the aerobic exercise will potentiate and increase the generalizability of the cognitive training. Importantly, this study will focus on older adults at-risk for mobility disability. This area is of particular importance considering a large percentage of adults are entering old age and therefore likely to suffer from age-related cognitive decline and mobility disability.
Background: Currently the United States has over 23 million Veterans. Of this number, 39.1 percent are over the age of 65 a number that will greatly increase as a large percent of the US population ages. Unfortunately, many of these individuals will suffer from some form of age-related cognitive decline and/or mobility disability. Significantly, declining mental health and mobility disability are primary components of the expected 25 percent growth in health care cost related to the aging crisis in America. And, despite the fact that the United States federal government spends $100 billion dollars annually to cure and/or treat cognitive impairments, successful strategies to improve these impairments remain elusive. The proposed research will substantially advance the development of treatments for cognitive and mobility impairment because the goals explore an intervention that may potentially have pervasive effects on US Veterans quality of life and well-being from a physical as well as a cognitive standpoint.
Methods and Research Plan: To address the investigators' research question 60 adults (age 18-89) will be randomized to one of two 12 week intervention groups: 1) Cognitive Training alone (CT) or 2) Aerobic Exercise + Cognitive Training (AE+CT). The aerobic exercise arm of the study will follow the same format shown to improve a broad range of cognitive functions in older adults in previous research. The cognitive training arm will consists of a popular commercially-available brain fitness program that has demonstrated specific cognitive improvements and high adherence.
Baseline testing will consist of a battery of cognitive function that target verbal fluency, response inhibition, and working memory. Additionally, participant will undergo a structural and functional MRI. Participants will also be evaluated on their physical function as assessed by a 400 meter walk, balance tests, and questionnaires about their daily l functioning. And lastly, all participants will be assessed on their aerobic capacity and for visual outcomes and serum BDNF. Following the 12-week intervention all participants will be post tested in the same manner as the baseline testing.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Georgia
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Decatur, Georgia, United States, 30033
- Atlanta VA Medical and Rehab Center, Decatur, GA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Right handed
- English speaking
- Aged 18 to 89
- Sedentary as defined by < 120 min/week of aerobic exercise over prior 3 months
- Non-demented (MMSE 24)
Exclusion Criteria:
- Severe diabetes requiring insulin
- Cognitive-executive function deficit (MoCA < 26)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic Exercise + Cognitive Training Group
Exercise 3 times a week on a stationary ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes per session; plus 20 minutes of cognitive training using Mindfit program
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stationary bicycling
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Active Comparator: Cognitive Training Only Group
Cognitive Training Only Group.
For this arm of the intervention, randomized participants followed the same guidelines as the cognitive component of the AE+CT group but did not partake in aerobic exercise.
To equalize contact/monitoring of the groups this group met for the same total duration time as the AE+CT group; however, instead of aerobic exercise, progressive whole body stretching and toning exercises
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20 minutes of cognitive training using Mindfit program
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change Executive Language Functions (Category Verbal Fluency)
Time Frame: change from pre and post separated by 12 weeks
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The Category Verbal Fluency Test is demonstrated to be reliable and valid among adults aged 50 to 89.
For Category Verbal Fluency, participants are asked to generate words from a category (e.g., colors) within 60 seconds.
A higher change score represents better performance on the outcome.
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change from pre and post separated by 12 weeks
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- B8034-W
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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